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Renal Disease, End-StageIHDIPNCT03239808

Incremental Haemodialysis in Incident Patients

A study testing Incremental haemodialysis and Conventional haemodialysis in people with Renal Disease, End-Stage, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura at 3 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Disease, End-Stage
What is being tested?
Incremental haemodialysis and Conventional haemodialysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
3 sitesSpain
Study dates
14 Mar 2018to 30 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged >18 years, incident patients with stage 5 CKD who have chosen HD as RRT initiation.
  • RRF measured by KrU ≥ 4 ml/min/1.73m2. In general, it is advised not to start HD with a KrU> 7.
  • Informed consent signed before starting any activity related to the trial.

Who cannot join

  • Unplanned HD initiation (established in point 7.4 of the protocol)
  • Non incident patients, in other words, patients who were previously on RRT, either on peritoneal dialysis, or on kidney transplant.
  • Active neoplasia at the moment of inclusion
  • Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA), unstable angina or ischemic cardiopathy which has caused any admission in hospital in the last 3 months.
  • Cardiorenal syndrome
  • Active inflammatory disease with immunosuppressive treatment
  • Hepatorenal syndrome

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • FundeSalud. Junta de Extremadura

    Mérida, Badajoz, 06800

  • Hospital Virgen del Puerto

    Plasencia, Cáceres, 10600

Other trials in Spain

About this study

Official title: Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients

Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD -one or two sessions per week-, is lower than that for conventional HD three times per week. Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines.

Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (incremental HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency.

Discussion: This study will enable us to know with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF.

Read the detailed description

Conventional thrice-weekly HD for 3 to 5 hours in a health center in an outpatient basis is the most used renal replacement therapy (RRT) regimen (1). However, it has an unacceptable high mortality rate (10%-20% a year). In order to try to improve those results, new regimens have been proposed. They are based on an increase of the HD dose and/or a higher number of sessions (2). Nevertheless, inconsistent results in terms of clinical benefits with such programs have been shown in recently published randomized and controlled trials (3,4), together with a lower rate of vascular access success (5) and a lower maintenance of the RRF (6) The National Kidney Foundation-Kidney Disease Outcomes Quality Initiate (NKD KDOQI 2015)(1) 2015 guidelines allow the reduction in the weekly HD dose for patients with a residual kidney urea clearance (KrU) higher than 3ml/min/1.73m2. In these cases, the renal clearance (Kr) is added to the dialysis clearance (Kd) obtained in 2 sessions per week, thus obtaining the adequate dialysis dose (7,8) Surprisingly enough, few centers follow this recommendation when over 50% of patients start HD with KrU >3 mL/min (9).

Authors like Kalantar-Zadeh et al (9,10) in the U.S.A. or Teruel et al (11) in Spain have published their experience with 2 HD sessions per week in incident patients. Through this regime they have shown that the RRF is preserved and the survival rate is similar to the one obtained with the conventional HD. This is due to the fact that the Kr has much greater clinical weight than Kd7, since the RRF contributes to the production of vitamin D and erythropoietine (12,13), and eliminates the protein-bound uremic toxins that are poorly dialyzed (13,14). In other words, the RRF plays a fundamental role both in the dialysis adequacy and in survival (15,16).

Currently, some authors are questioning the number of HD sessions with which a patient should start the renal replacement therapy (RRT) (7, 17-19). Progressive HD is an initiation regimen adapted to the patient's RRF. The frequency increases as the daily diuretic level declines (7, 17-19).

The IHDIP trial20 aims at determining whether or not starting with one HD session per week reduces mortality in incident patients and its influence in morbidity (hospital admissions), clinical parameters, quality of life and efficiency with regard to the patients who start RRT with the conventional method.

Being tested
Incremental haemodialysis, Conventional haemodialysis
Keywords
once-weekly haemodialysis, incremental haemodialysis, randomized clinical trial
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incremental haemodialysisProcedure or surgery

    It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression

  • Conventional haemodialysisProcedure or surgery

    It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).

Study groups in NCT03239808
Study groupRoleWhat they receive
Experimental groupExperimental76 patients who start RRT with the incremental HD regimen.
Receives: Procedure: Incremental haemodialysis
Control groupActive comparator76 patients who start RRT with the conventional HD (3 sessions per week)
Receives: Procedure: Conventional haemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate

    Assess and compare survival in subjects with one session a week as an RRT starting regimen, compared to those patients who start RRT with the conventional method

    Measured: 24 months

Secondary outcomes (7)

  1. Hospital admissions

    Number of hospitalizations, for any cause; and number of days hospitalized for any cause

    Measured: 24 months

  2. Residual Kidney Function (RRF) maintenance .

    Reduction of glomerular filtration rate (GFR) and tubular function. Average urine volume and percentage of patients with anuria (≤200ml/day in two consecutive measurements).

    Measured: 24 months

  3. Analysis of anemia

    Mean hemoglobin levels and Proportion of patients with Hb measurement inside the target range (10.5-12 g/dl) and The erythropoietin resistance index (ERI): ERI = weekly EPO (in UI)/patient's weight (in kg)/Hb (in gr/dl)

    Measured: 3, 6, 9, 12, 18 and 24 months

  4. Bone-mineral metabolism

    Mean levels of calcium, phosphorus and intac PTH levels. Estimate the percentage of patients within the therapeutic range; Calcium 8,4-9,5mg/dl, Phosphorus 3,5-5,5mg/dl and iPTH 150-300 pg/dl.

    Measured: 3, 6, 9, 12, 18 and 24 months

  5. Hypertrophic cardiomyopathy levels

    Measured: Basal, anual and end of the follow-un visit

  6. Estimation of the effect of treatment on quality of life

    Quality of life survey values from Kidney Disease and Quality of Life (KDQOL'36 Spanish) will be registered.

    Measured: 3, 6, 9, 12, 18 and 24 months

  7. Assessing RRT efficiency (costs)

    The number of sessions perform in subjects of incremental HDF group Vs number of sessions in the conventional HD group. The cost of each session is defined by the public contest for private haemodialysis clinics arranged by (that work to) the Health Service of Extremadura.

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2017
  2. Study start14 Mar 2018
  3. Primary completion6 Jun 2024
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, multicenter, randomized clinical trial. It has two strata: for age (≥or\< 75 years old) and for KrU (≥or\< 5,5 ml/min/1.73m2). It is controlled through usual clinical practice. Intervention consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression.
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03239808
Sponsor's protocol ID
IHDIP (P1712)
Acronym
IHDIP
Status last verified
Mar 2025
First submitted
4 Jul 2017
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.

    PubMed 26498416

  • Chan CT, Covic A, Craig JC, Davenport A, Kasiske BL, Kuhlmann MK, Levin NW, Li PK, Locatelli F, Rocco MV, Wheeler DC. Novel techniques and innovation in blood purification: a clinical update from Kidney Disease: Improving Global Outcomes. Kidney Int. 2013 Mar;83(3):359-71. doi: 10.1038/ki.2012.450. Epub 2013 Jan 16.

    PubMed 23325091

  • Chertow GM, Levin NW, Beck GJ, Daugirdas JT, Eggers PW, Kliger AS, Larive B, Rocco MV, Greene T; Frequent Hemodialysis Network (FHN) Trials Group. Long-Term Effects of Frequent In-Center Hemodialysis. J Am Soc Nephrol. 2016 Jun;27(6):1830-6. doi: 10.1681/ASN.2015040426. Epub 2015 Oct 14.

    PubMed 26467779

  • Rocco MV, Daugirdas JT, Greene T, Lockridge RS, Chan C, Pierratos A, Lindsay R, Larive B, Chertow GM, Beck GJ, Eggers PW, Kliger AS; FHN Trial Group. Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial. Am J Kidney Dis. 2015 Sep;66(3):459-68. doi: 10.1053/j.ajkd.2015.02.331. Epub 2015 Apr 8.

    PubMed 25863828

  • Suri RS, Larive B, Sherer S, Eggers P, Gassman J, James SH, Lindsay RM, Lockridge RS, Ornt DB, Rocco MV, Ting GO, Kliger AS; Frequent Hemodialysis Network Trial Group. Risk of vascular access complications with frequent hemodialysis. J Am Soc Nephrol. 2013 Feb;24(3):498-505. doi: 10.1681/ASN.2012060595. Epub 2013 Feb 7.

    PubMed 23393319

  • Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.

    PubMed 23344474

  • Clark EG, Bagshaw SM. Unnecessary renal replacement therapy for acute kidney injury is harmful for renal recovery. Semin Dial. 2015 Jan-Feb;28(1):6-11. doi: 10.1111/sdi.12300. Epub 2014 Oct 30.

    PubMed 25359104

  • Mathew AT, Fishbane S, Obi Y, Kalantar-Zadeh K. Preservation of residual kidney function in hemodialysis patients: reviving an old concept. Kidney Int. 2016 Aug;90(2):262-271. doi: 10.1016/j.kint.2016.02.037. Epub 2016 May 12.

    PubMed 27182000

  • Patel N, Hu SL. Preserving residual renal function in dialysis: what we know. Semin Dial. 2015 May-Jun;28(3):250-8. doi: 10.1111/sdi.12302. Epub 2014 Sep 18.

    PubMed 25231758

  • Casino FG, Basile C. The variable target model: a paradigm shift in the incremental haemodialysis prescription. Nephrol Dial Transplant. 2017 Jan 1;32(1):182-190. doi: 10.1093/ndt/gfw339.

    PubMed 27742823

  • Shafi T, Jaar BG, Plantinga LC, Fink NE, Sadler JH, Parekh RS, Powe NR, Coresh J. Association of residual urine output with mortality, quality of life, and inflammation in incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Am J Kidney Dis. 2010 Aug;56(2):348-58. doi: 10.1053/j.ajkd.2010.03.020. Epub 2010 Jun 3.

    PubMed 20605303

  • van der Wal WM, Noordzij M, Dekker FW, Boeschoten EW, Krediet RT, Korevaar JC, Geskus RB; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group (NECOSAD). Full loss of residual renal function causes higher mortality in dialysis patients; findings from a marginal structural model. Nephrol Dial Transplant. 2011 Sep;26(9):2978-83. doi: 10.1093/ndt/gfq856. Epub 2011 Feb 11.

    PubMed 21317411

  • Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9.

    PubMed 26867814

  • Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1.

    PubMed 26038351

  • Termorshuizen F, Dekker FW, van Manen JG, Korevaar JC, Boeschoten EW, Krediet RT; NECOSAD Study Group. Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. J Am Soc Nephrol. 2004 Apr;15(4):1061-70. doi: 10.1097/01.asn.0000117976.29592.93.

    PubMed 15034110

Questions about this trial

What is this clinical trial studying?

A study testing Incremental haemodialysis and Conventional haemodialysis in people with Renal Disease, End-Stage, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03239808, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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